Hailie Sensor - for use only with Ellipta DPI

GUDID 00942103218039

Inhaler dose sensor

ADHERIUM (NZ) LIMITED

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• Primary Device ID: 00942103218039
• NIH Device Record Key: ef7585e7-fe3e-4d8f-a48a-854bddc64e5a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hailie Sensor - for use only with Ellipta DPI
• Version Model Number: NF0110
• Company DUNS: 590654401
• Company Name: ADHERIUM (NZ) LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00942103218039 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220622

FDA Product Code

• CAF: Nebulizer (Direct Patient Interface)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-11-22
• Device Publish Date: 2022-11-14

On-Brand Devices [Hailie Sensor - for use only with Ellipta DPI]

• 09421032180385: Inhaler dose sensor
• 00942103218039: Inhaler dose sensor